General Thoracic

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

Hospitals and hospitalists should ex­pect more aggressive enforcement of protected health information reg­ulations following a $1 million settlement paid by Massachusetts General Physicians Organization Inc. over documents on 192 patients left on the subway by a MassGen employee, a top hospitalist says.

The payment – part of an agreement between MassGen and the U.S. Health and Human Services Department over “potential violations” of HIPAA rules – came at the same time as HHS issued its first civil money penalty for violations of the privacy act. The $4.3 million civil money penalty involved Cignet Health Care, a Maryland-based clinic, which

********* TEXT BREAK *********HHS found had violated 41 patients’ rights by failing to provide them with ac­cess to their own medical records.

Dr. Chad Whelan, director of the di­vision of hospital medicine at Loyola University Chicago, Maywood, said the two high-dollar enforcement moves by HHS indicate more aggressive enforce­ment of HIPAA is coming.

<[stk -3.7]>“Given the large fines and the high-pro­file institution [MassGen] affected, it sure seems like they are sending a message,” he said in an interview. “I would fully expect more stringent enforcement in the coming years, and we will likely see more payouts.”<[etk]>

<[stk -3]>To safeguard themselves, physicians and hospitals need to take a hard look at their policies regarding electronic storage and transmission of protected health infor­mation across multiple electronic devices, especially smartphones and tablet-style electronic devices, Dr. Whelan said.<[etk]>

“The beautiful thing about computers, smartphones, and electronic medical records is that [they make it] amazingly easy to store, access, and share informa­tion,” he said. “The terrifying thing about computers, smartphones, and elec­tronic medical records is that [they make it] amazingly easy to store, access, and share information.

<[stk -1]>“Medical centers and hospitalists must be aware of this tension between im­proving care through information access and sharing and the risk to confidential­ity through easier information access and sharing. These settlements are the first shot across the bow to all of us that HHS is certainly taking a long, hard look at this balance,” he said.<[etk]>

<[stk -3]>Office of Civil Rights director Georgina Verdugo said as much in a statement in­volving the MassGen settlement. “We hope the health care industry will take a close look at this agreement and recognize that the OCR is serious about HIPAA en­forcement. It is a covered entity’s respon­sibility to protect its patients’ health information,” Ms. Verdugo said.<[etk]>

The MassGen incident involved hard copies of protected health information from the hospital’s Infectious Disease Associates outpatient practice, and in­cluded patients with HIV and AIDS, ac­cording to HHS. The documents involved included a patient schedule with names for all of the patients, plus billing encounter forms with identifying infor­mation such as name, date of birth, health insurer, and policy number for 66 of the same patients.

A MassGen employee left the infor­mation on a subway while commuting to work, and it was never recovered. One of the patients involved filed a complaint with HHS, which investigated and found that MassGen had “failed to implement reasonable, appropriate safeguards to protect the privacy of [protected health information] when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating pro­visions of the HIPAA Privacy Rule.”

MassGen said in a statement that it will implement a corrective action plan over the next 3 years designed to en­hance protection of protected health in­formation when it is physically removed from the hospital’s property for work purposes. The organization also said it will issue new or revised policies and procedures dealing with laptop encryp­tion and USB drive encryption.

“After these policies and procedures are issued, we will be providing manda­tory training on them,” the hospital said. “All members of our workforce must participate in the training and certify that they have completed it.”

It’s very unusual for an employee to intentionally violate HIPAA, but it’s the inadvertent violations that can cause trouble. “It is far more likely that a well-meaning employee simply forgets the ba­sics of patient protection on a device and then accidentally misplaces the device, leaving it open for anyone with basic computer skills to access,” he said.

Traditional concern has been focused on data stored on portable computer
hardware, such as hard drives, CDs, and laptops, he said. But “with the increased availability of electronic medical records, it will only become easier to have infor­mation about patients in portable for­mats. With paper, it was difficult to carry records of hundreds of patients around. Now, it is remarkably easy.”

<[stk -3]>The rise of extremely portable devices such as smart phones and iPads poses new risks, Dr. Whelan said. “How many peo­ple have patient information stored or ac­cessible through these omnipresent devices? Certainly, patient information that has been sent through e-mail is easi­ly accessed through a smartphone. Hos­pitals need to develop policies around encryption and support end users in en­crypting the multiple devices they may use to levels that are acceptable to HHS.”<[etk]>

I have checked the following facts in my story: (Please initial each.)

·Drug names and dosages n.a.

<[stk -3]>In order to better safeguard protected data, hospitals need to have enterprise-wide programs in data information man­agement, but also need to help employees make certain any data-storage or trans­mission devices they use are HIPAA-com­pliant, Dr. Whelan said. <[etk]>

<[stk -3]>“Hospitalists should be involved in both policy development and process imple­mentation to assure that the benefits of electronic data storage are not lost in or­der to reduce the risk of HIPAA viola­tion,” he added.

Hospitals and hospitalists should ex­pect more aggressive enforcement of protected health information reg­ulations following a $1 million settlement paid by Massachusetts General Physicians Organization Inc. over documents on 192 patients left on the subway by a MassGen employee, a top hospitalist says.

The payment – part of an agreement between MassGen and the U.S. Health and Human Services Department over “potential violations” of HIPAA rules – came at the same time as HHS issued its first civil money penalty for violations of the privacy act. The $4.3 million civil money penalty involved Cignet Health Care, a Maryland-based clinic, which

********* TEXT BREAK *********HHS found had violated 41 patients’ rights by failing to provide them with ac­cess to their own medical records.

Dr. Chad Whelan, director of the di­vision of hospital medicine at Loyola University Chicago, Maywood, said the two high-dollar enforcement moves by HHS indicate more aggressive enforce­ment of HIPAA is coming.

<[stk -3.7]>“Given the large fines and the high-pro­file institution [MassGen] affected, it sure seems like they are sending a message,” he said in an interview. “I would fully expect more stringent enforcement in the coming years, and we will likely see more payouts.”<[etk]>

<[stk -3]>To safeguard themselves, physicians and hospitals need to take a hard look at their policies regarding electronic storage and transmission of protected health infor­mation across multiple electronic devices, especially smartphones and tablet-style electronic devices, Dr. Whelan said.<[etk]>

“The beautiful thing about computers, smartphones, and electronic medical records is that [they make it] amazingly easy to store, access, and share informa­tion,” he said. “The terrifying thing about computers, smartphones, and elec­tronic medical records is that [they make it] amazingly easy to store, access, and share information.

<[stk -1]>“Medical centers and hospitalists must be aware of this tension between im­proving care through information access and sharing and the risk to confidential­ity through easier information access and sharing. These settlements are the first shot across the bow to all of us that HHS is certainly taking a long, hard look at this balance,” he said.<[etk]>

<[stk -3]>Office of Civil Rights director Georgina Verdugo said as much in a statement in­volving the MassGen settlement. “We hope the health care industry will take a close look at this agreement and recognize that the OCR is serious about HIPAA en­forcement. It is a covered entity’s respon­sibility to protect its patients’ health information,” Ms. Verdugo said.<[etk]>

The MassGen incident involved hard copies of protected health information from the hospital’s Infectious Disease Associates outpatient practice, and in­cluded patients with HIV and AIDS, ac­cording to HHS. The documents involved included a patient schedule with names for all of the patients, plus billing encounter forms with identifying infor­mation such as name, date of birth, health insurer, and policy number for 66 of the same patients.

A MassGen employee left the infor­mation on a subway while commuting to work, and it was never recovered. One of the patients involved filed a complaint with HHS, which investigated and found that MassGen had “failed to implement reasonable, appropriate safeguards to protect the privacy of [protected health information] when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating pro­visions of the HIPAA Privacy Rule.”

MassGen said in a statement that it will implement a corrective action plan over the next 3 years designed to en­hance protection of protected health in­formation when it is physically removed from the hospital’s property for work purposes. The organization also said it will issue new or revised policies and procedures dealing with laptop encryp­tion and USB drive encryption.

“After these policies and procedures are issued, we will be providing manda­tory training on them,” the hospital said. “All members of our workforce must participate in the training and certify that they have completed it.”

It’s very unusual for an employee to intentionally violate HIPAA, but it’s the inadvertent violations that can cause trouble. “It is far more likely that a well-meaning employee simply forgets the ba­sics of patient protection on a device and then accidentally misplaces the device, leaving it open for anyone with basic computer skills to access,” he said.

Traditional concern has been focused on data stored on portable computer
hardware, such as hard drives, CDs, and laptops, he said. But “with the increased availability of electronic medical records, it will only become easier to have infor­mation about patients in portable for­mats. With paper, it was difficult to carry records of hundreds of patients around. Now, it is remarkably easy.”

<[stk -3]>The rise of extremely portable devices such as smart phones and iPads poses new risks, Dr. Whelan said. “How many peo­ple have patient information stored or ac­cessible through these omnipresent devices? Certainly, patient information that has been sent through e-mail is easi­ly accessed through a smartphone. Hos­pitals need to develop policies around encryption and support end users in en­crypting the multiple devices they may use to levels that are acceptable to HHS.”<[etk]>

I have checked the following facts in my story: (Please initial each.)

·Drug names and dosages n.a.

<[stk -3]>In order to better safeguard protected data, hospitals need to have enterprise-wide programs in data information man­agement, but also need to help employees make certain any data-storage or trans­mission devices they use are HIPAA-com­pliant, Dr. Whelan said. <[etk]>

<[stk -3]>“Hospitalists should be involved in both policy development and process imple­mentation to assure that the benefits of electronic data storage are not lost in or­der to reduce the risk of HIPAA viola­tion,” he added.

Hospitals and hospitalists should ex­pect more aggressive enforcement of protected health information reg­ulations following a $1 million settlement paid by Massachusetts General Physicians Organization Inc. over documents on 192 patients left on the subway by a MassGen employee, a top hospitalist says.

The payment – part of an agreement between MassGen and the U.S. Health and Human Services Department over “potential violations” of HIPAA rules – came at the same time as HHS issued its first civil money penalty for violations of the privacy act. The $4.3 million civil money penalty involved Cignet Health Care, a Maryland-based clinic, which

********* TEXT BREAK *********HHS found had violated 41 patients’ rights by failing to provide them with ac­cess to their own medical records.

Dr. Chad Whelan, director of the di­vision of hospital medicine at Loyola University Chicago, Maywood, said the two high-dollar enforcement moves by HHS indicate more aggressive enforce­ment of HIPAA is coming.

<[stk -3.7]>“Given the large fines and the high-pro­file institution [MassGen] affected, it sure seems like they are sending a message,” he said in an interview. “I would fully expect more stringent enforcement in the coming years, and we will likely see more payouts.”<[etk]>

<[stk -3]>To safeguard themselves, physicians and hospitals need to take a hard look at their policies regarding electronic storage and transmission of protected health infor­mation across multiple electronic devices, especially smartphones and tablet-style electronic devices, Dr. Whelan said.<[etk]>

“The beautiful thing about computers, smartphones, and electronic medical records is that [they make it] amazingly easy to store, access, and share informa­tion,” he said. “The terrifying thing about computers, smartphones, and elec­tronic medical records is that [they make it] amazingly easy to store, access, and share information.

<[stk -1]>“Medical centers and hospitalists must be aware of this tension between im­proving care through information access and sharing and the risk to confidential­ity through easier information access and sharing. These settlements are the first shot across the bow to all of us that HHS is certainly taking a long, hard look at this balance,” he said.<[etk]>

<[stk -3]>Office of Civil Rights director Georgina Verdugo said as much in a statement in­volving the MassGen settlement. “We hope the health care industry will take a close look at this agreement and recognize that the OCR is serious about HIPAA en­forcement. It is a covered entity’s respon­sibility to protect its patients’ health information,” Ms. Verdugo said.<[etk]>

The MassGen incident involved hard copies of protected health information from the hospital’s Infectious Disease Associates outpatient practice, and in­cluded patients with HIV and AIDS, ac­cording to HHS. The documents involved included a patient schedule with names for all of the patients, plus billing encounter forms with identifying infor­mation such as name, date of birth, health insurer, and policy number for 66 of the same patients.

A MassGen employee left the infor­mation on a subway while commuting to work, and it was never recovered. One of the patients involved filed a complaint with HHS, which investigated and found that MassGen had “failed to implement reasonable, appropriate safeguards to protect the privacy of [protected health information] when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating pro­visions of the HIPAA Privacy Rule.”

MassGen said in a statement that it will implement a corrective action plan over the next 3 years designed to en­hance protection of protected health in­formation when it is physically removed from the hospital’s property for work purposes. The organization also said it will issue new or revised policies and procedures dealing with laptop encryp­tion and USB drive encryption.

“After these policies and procedures are issued, we will be providing manda­tory training on them,” the hospital said. “All members of our workforce must participate in the training and certify that they have completed it.”

It’s very unusual for an employee to intentionally violate HIPAA, but it’s the inadvertent violations that can cause trouble. “It is far more likely that a well-meaning employee simply forgets the ba­sics of patient protection on a device and then accidentally misplaces the device, leaving it open for anyone with basic computer skills to access,” he said.

Traditional concern has been focused on data stored on portable computer
hardware, such as hard drives, CDs, and laptops, he said. But “with the increased availability of electronic medical records, it will only become easier to have infor­mation about patients in portable for­mats. With paper, it was difficult to carry records of hundreds of patients around. Now, it is remarkably easy.”

<[stk -3]>The rise of extremely portable devices such as smart phones and iPads poses new risks, Dr. Whelan said. “How many peo­ple have patient information stored or ac­cessible through these omnipresent devices? Certainly, patient information that has been sent through e-mail is easi­ly accessed through a smartphone. Hos­pitals need to develop policies around encryption and support end users in en­crypting the multiple devices they may use to levels that are acceptable to HHS.”<[etk]>

I have checked the following facts in my story: (Please initial each.)

·Drug names and dosages n.a.

<[stk -3]>In order to better safeguard protected data, hospitals need to have enterprise-wide programs in data information man­agement, but also need to help employees make certain any data-storage or trans­mission devices they use are HIPAA-com­pliant, Dr. Whelan said. <[etk]>

<[stk -3]>“Hospitalists should be involved in both policy development and process imple­mentation to assure that the benefits of electronic data storage are not lost in or­der to reduce the risk of HIPAA viola­tion,” he added.

DETROIT – Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 sur­geons over the next 20 years.

“We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bid­ding wars,” Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

“In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today.”

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical spe­cialties: obstetrics and gynecology, or­thopedic surgery, general surgery, otolaryngology, urology, neurosurgery,
and thoracic surgery (Ann. Surg. 2009;250:590-7). I’ve searched and can’t find the print reference. Help?—EW The trick is to search by the article name in Google. I got abut 5 different versions that way./CNW»

The current analysis went one step fur­ther, focusing on the average recruit­ment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population re­ceiving care at urban and rural hospitals will remain constant, Dr. Williams ex­plained.

Currently, the American Hospital As­sociation estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hos­pitals serving 18% or 56 million Ameri­cans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and re­tain 4,175 surgeons per year or 27.7 sur­geons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams «not facs»of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dra­matic loss of general surgeons.

“In rural hospitals, general surgery is essential,” he said. “[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their ad­ministrators of retiring or leaving in 2 years. Thirty-three percent of rural hos­pitals are recruiting now.”

Factors that might make rural re­cruitment more difficult include profes­sional and social isolation, cross coverage, insufficient training for the va­riety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, indepen­dence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon to­ward a rural hospital is doing a residen­cy in a rural training program. The researchers estimate that half of gener­al surgery residents who rotate through such a program will go on to practice in rural towns.

“It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals,” Dr. Williams said.

Consideration of the needs of the sur­geon’s family is another factor. Typical­
ly, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician cou­ple. Thus, educational loan repayment could be a potential “trump card” for rur­al hospitals in the future, he said.

Rural hospitals are already throw­ing out the wel­come mat. Most offer hiring incen­tives such as a re­location allowance; signing bonus; health, dis­ability, and life in­surance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hos­pitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

“In many general surgery programs in the United States, senior residents are re­ceiving as many as 50 offers for employ­ment today,” he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an or­thopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full ben­efits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Sop­er, «facs»chair of the department of surgery at Northwestern University in Chicago, said, “It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done.”

Dr. Sober suggested that the basic problem is not so much the division be­tween rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhag­wan Satiani replied that the analysis in­cluded a simplified version of the federal model used to calculate supply and de­mand, but added that every projection in the last 50-75 years has been wrong. “You have to look at this model and say, ‘This is the best we can do right now,” he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive med­ical school rural program (MSRP). “If you took 10 medical students out of the class and put them into the MSRP pro­
gram, you could double the number of rural surgeons. That’s how important that is,” said Dr. Satiani, «facs»medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia pro­vides a similar cal­culation for rural physicians and re­ports that 79%-87% of graduates from the two MSRPs with long-range rural out­comes – the PSAP and University of Minnesota at Duluth – remained in rur­al practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Af­fordable Care Act authorized a new Rur­al Physician Training Grants program to provide grants to medical schools to de­velop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be consid­ered programs that attract rural sur­geons, according to Dr. Satiani. “I think American surgery is going to have to give this a separate tract within residency programs.”

Audience member Dr. Mark Malan­goni, «facs»associate executive director of the American Board of Surgery in Philadel­phia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Wash­ington state.

He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural ar­eas.

Finally, several audience members sug­gested that efforts need to be made to eliminate the perception among resi­dents that surgical specialists are some­how better than general surgeons.

“It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists,” Dr. Satiani said. “I think it has to come from the programs and the leadership; defin­ing general surgery better, even going as far as changing the name, if that be­comes an important issue.”

When asked in an interview what that new name might be, Dr. Satiani said the terms “master surgeon” and “omni sur­geon” have been floated, with master surgeon more likely to resonate with the general public.

I have checked the following facts in my story: (Please initial each.)

The authors reported no conflicts of interest. 

DETROIT – Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 sur­geons over the next 20 years.

“We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bid­ding wars,” Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

“In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today.”

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical spe­cialties: obstetrics and gynecology, or­thopedic surgery, general surgery, otolaryngology, urology, neurosurgery,
and thoracic surgery (Ann. Surg. 2009;250:590-7). I’ve searched and can’t find the print reference. Help?—EW The trick is to search by the article name in Google. I got abut 5 different versions that way./CNW»

The current analysis went one step fur­ther, focusing on the average recruit­ment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population re­ceiving care at urban and rural hospitals will remain constant, Dr. Williams ex­plained.

Currently, the American Hospital As­sociation estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hos­pitals serving 18% or 56 million Ameri­cans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and re­tain 4,175 surgeons per year or 27.7 sur­geons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams «not facs»of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dra­matic loss of general surgeons.

“In rural hospitals, general surgery is essential,” he said. “[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their ad­ministrators of retiring or leaving in 2 years. Thirty-three percent of rural hos­pitals are recruiting now.”

Factors that might make rural re­cruitment more difficult include profes­sional and social isolation, cross coverage, insufficient training for the va­riety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, indepen­dence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon to­ward a rural hospital is doing a residen­cy in a rural training program. The researchers estimate that half of gener­al surgery residents who rotate through such a program will go on to practice in rural towns.

“It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals,” Dr. Williams said.

Consideration of the needs of the sur­geon’s family is another factor. Typical­
ly, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician cou­ple. Thus, educational loan repayment could be a potential “trump card” for rur­al hospitals in the future, he said.

Rural hospitals are already throw­ing out the wel­come mat. Most offer hiring incen­tives such as a re­location allowance; signing bonus; health, dis­ability, and life in­surance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hos­pitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

“In many general surgery programs in the United States, senior residents are re­ceiving as many as 50 offers for employ­ment today,” he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an or­thopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full ben­efits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Sop­er, «facs»chair of the department of surgery at Northwestern University in Chicago, said, “It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done.”

Dr. Sober suggested that the basic problem is not so much the division be­tween rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhag­wan Satiani replied that the analysis in­cluded a simplified version of the federal model used to calculate supply and de­mand, but added that every projection in the last 50-75 years has been wrong. “You have to look at this model and say, ‘This is the best we can do right now,” he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive med­ical school rural program (MSRP). “If you took 10 medical students out of the class and put them into the MSRP pro­
gram, you could double the number of rural surgeons. That’s how important that is,” said Dr. Satiani, «facs»medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia pro­vides a similar cal­culation for rural physicians and re­ports that 79%-87% of graduates from the two MSRPs with long-range rural out­comes – the PSAP and University of Minnesota at Duluth – remained in rur­al practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Af­fordable Care Act authorized a new Rur­al Physician Training Grants program to provide grants to medical schools to de­velop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be consid­ered programs that attract rural sur­geons, according to Dr. Satiani. “I think American surgery is going to have to give this a separate tract within residency programs.”

Audience member Dr. Mark Malan­goni, «facs»associate executive director of the American Board of Surgery in Philadel­phia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Wash­ington state.

He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural ar­eas.

Finally, several audience members sug­gested that efforts need to be made to eliminate the perception among resi­dents that surgical specialists are some­how better than general surgeons.

“It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists,” Dr. Satiani said. “I think it has to come from the programs and the leadership; defin­ing general surgery better, even going as far as changing the name, if that be­comes an important issue.”

When asked in an interview what that new name might be, Dr. Satiani said the terms “master surgeon” and “omni sur­geon” have been floated, with master surgeon more likely to resonate with the general public.

I have checked the following facts in my story: (Please initial each.)

The authors reported no conflicts of interest. 

DETROIT – Rural hospitals will need to devise unique strategies to enhance hiring and retention in the face of a looming shortage of almost 30,000 sur­geons over the next 20 years.

“We think this shortage will result in competition between urban and rural hospitals, maybe perpetuating in bid­ding wars,” Dr. Thomas E. Williams Jr. said at the annual meeting of the Central Surgical Association.

“In a sense, this shortage could be a perfect storm; an imperative for both the urban and rural hospitals we see in America today.”

The researchers previously reported that an estimated 101,838 surgeons will need to be trained by 2030 to address a projected shortage in the United States of 29,138 surgeons in seven surgical spe­cialties: obstetrics and gynecology, or­thopedic surgery, general surgery, otolaryngology, urology, neurosurgery,
and thoracic surgery (Ann. Surg. 2009;250:590-7). I’ve searched and can’t find the print reference. Help?—EW The trick is to search by the article name in Google. I got abut 5 different versions that way./CNW»

The current analysis went one step fur­ther, focusing on the average recruit­ment needs for the seven specialties in rural vs. urban hospitals in light of the projected U.S. population of 364 million by 2030. The model assumed that there will be equal population growth in urban and rural areas; that rural hospitals will need to recruit obstetric/gynecologic, orthopedic, and general surgeons; and that the percentage of the population re­ceiving care at urban and rural hospitals will remain constant, Dr. Williams ex­plained.

Currently, the American Hospital As­sociation estimates that there are 3,012 urban hospitals in the United States. serving 82% of the population or 253 million Americans, and 1,998 rural hos­pitals serving 18% or 56 million Ameri­cans.

Based on these assumptions, the total number of surgical hires over the next 19 years will be 83,507 for urban hospitals and 13,953 for rural hospitals. This means urban hospitals must hire and re­tain 4,175 surgeons per year or 27.7 sur­geons per hospital, while rural hospitals will need to hire 698 surgeons per year or 7 surgeons per hospital, said Dr. Williams «not facs»of the department of surgery at Ohio State University in Columbus.

While the recruitment goals for urban hospitals might appear more daunting, rural hospitals are already facing a dra­matic loss of general surgeons.

“In rural hospitals, general surgery is essential,” he said. “[General surgeons] account for 60% of the revenue. What’s happening now is that about 34% of general surgeons are notifying their ad­ministrators of retiring or leaving in 2 years. Thirty-three percent of rural hos­pitals are recruiting now.”

Factors that might make rural re­cruitment more difficult include profes­sional and social isolation, cross coverage, insufficient training for the va­riety of procedures performed and pathologies encountered, and women’s preference for urban areas, he said.

Factors that positively influence rural recruitment include the chance to be a critical part of the community, indepen­dence, the wide spectrum of procedures, and hailing from a rural area.

One strategy that can tip a surgeon to­ward a rural hospital is doing a residen­cy in a rural training program. The researchers estimate that half of gener­al surgery residents who rotate through such a program will go on to practice in rural towns.

“It’s to the advantage of rural hospital administrators to establish rotations with medical schools in their hospitals, so they can have the opportunity to recruit some of the people that rotate through their rural hospitals,” Dr. Williams said.

Consideration of the needs of the sur­geon’s family is another factor. Typical­
ly, this will be a two-income family that values education and will need either good public schools or the means to pay for private schools. Most couples will also have educational debts, some as high as $400,000 for a two-physician cou­ple. Thus, educational loan repayment could be a potential “trump card” for rur­al hospitals in the future, he said.

Rural hospitals are already throw­ing out the wel­come mat. Most offer hiring incen­tives such as a re­location allowance; signing bonus; health, dis­ability, and life in­surance; and malpractice coverage. Educational loan forgiveness was offered by 38% of hos­pitals last year, up 7% from 2009, Dr. Williams said. Still, competition for new hires is fierce.

“In many general surgery programs in the United States, senior residents are re­ceiving as many as 50 offers for employ­ment today,” he said.

To illustrate the point, Dr. Williams showed a recent classified ad in the New England Journal of Medicine offering a starting base salary of $600,000 for an or­thopedic surgeon in coastal Georgia plus a sign-on and relocation bonus, full ben­efits, and a high-yield bonus. This is nearly double the median starting salary of $370,000 for an orthopedic surgeon identified in a recent Cejka Executive Search survey, he pointed out.

Median starting salaries for the seven surgical specialties studied ranged from a low of $260,000 for a general surgeon to a high of $450,000 for a neurosurgeon in the Cejka survey.

Invited discussant Dr. Nathaniel Sop­er, «facs»chair of the department of surgery at Northwestern University in Chicago, said, “It may end up being ultimately that these bidding wars are good for general surgeons, but I think it’s not going to be good for the population we serve, as there is going to be a shortage unless something is done.”

Dr. Sober suggested that the basic problem is not so much the division be­tween rural vs. urban, but the supply of surgeons, and asked what can be done to meet the estimated shortfall. He also questioned the model’s assumption that the population would remain equal in rural and urban areas.

Co-author and colleague Dr. Bhag­wan Satiani replied that the analysis in­cluded a simplified version of the federal model used to calculate supply and de­mand, but added that every projection in the last 50-75 years has been wrong. “You have to look at this model and say, ‘This is the best we can do right now,” he said.

According to Dr. Satiani, one of the best ways to increase the rural surgeon supply is through a comprehensive med­ical school rural program (MSRP). “If you took 10 medical students out of the class and put them into the MSRP pro­
gram, you could double the number of rural surgeons. That’s how important that is,” said Dr. Satiani, «facs»medical director of the vascular surgery laboratory and a professor of clinical surgery at Ohio State University.

A recently published report from the Physician Shortage Area Program (PSAP) at Jefferson Medical College in Philadelphia pro­vides a similar cal­culation for rural physicians and re­ports that 79%-87% of graduates from the two MSRPs with long-range rural out­comes – the PSAP and University of Minnesota at Duluth – remained in rur­al practice for up to 20 years (Acad. Med. 2011;86:272). It also notes that the Af­fordable Care Act authorized a new Rur­al Physician Training Grants program to provide grants to medical schools to de­velop or expand MSRPs.

Only 25 of the roughly 250 medical schools have general surgery programs, and just 10% of these could be consid­ered programs that attract rural sur­geons, according to Dr. Satiani. “I think American surgery is going to have to give this a separate tract within residency programs.”

Audience member Dr. Mark Malan­goni, «facs»associate executive director of the American Board of Surgery in Philadel­phia, pointed out that in such rural areas as Wyoming, the closest medical school is more than 1,000 miles away in Wash­ington state.

He suggested that one way to link rural hospitals and to counteract the professional isolation experienced by some rural physicians is through Web-based surgeon-to-surgeon consultations, an idea strongly supported by a recent survey of American College of Surgeons fellows.

If a new medical school were located in a rural area, Dr. Satiani said it could feed two to three nearby states, but not one of the new medical schools built in the last 5 years has been in truly rural ar­eas.

Finally, several audience members sug­gested that efforts need to be made to eliminate the perception among resi­dents that surgical specialists are some­how better than general surgeons.

“It’s the one-on-one thing that’s going to work with the residents, because all they see are these super-specialists,” Dr. Satiani said. “I think it has to come from the programs and the leadership; defin­ing general surgery better, even going as far as changing the name, if that be­comes an important issue.”

When asked in an interview what that new name might be, Dr. Satiani said the terms “master surgeon” and “omni sur­geon” have been floated, with master surgeon more likely to resonate with the general public.

I have checked the following facts in my story: (Please initial each.)

The authors reported no conflicts of interest. 

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

SAN FRANCISCO – Endo­scopic resection may help man­agement of clinically node– negative superficial squamous cell carcinoma of the esophagus, new data from Japan suggest.

<[stk -1]>A retrospective study of 83 patients who had endoscopic re­section and subsequent treat­ment because of the depth of cancer invasion found a 5-year survival rate of 76% when fol­lowed by chemoradiation and 100% when followed by surgery.<[etk]>

<[stk -1]>The most common complica­tion of the endoscopic resection was stenosis, noted in 11% of cases overall, lead investigator Dr. Toshiro Iizuka, a gastroen­terologist at Toranomon Hospi­tal in Tokyo, reported at the meeting  on gastrointestinal can­cers sponsored by the American Society of Clinical Oncology.

“Endoscopic therapy plus ad­ditional treatment for M3 to SM2 superficial carcinoma of the esophagus did not entail the development of any serious complications. Thus, such com­bined treatment was safe and feasible,” Dr. Iizuka comment­ed. “The long-term follow-up results were fairly gratifying.”

“Surgical resection has been considered as a standard treat­ment in cases of superficial esophageal cancer with poten­tial lymph node metastasis,” but up to two-thirds of patients ex­perience serious complications.

<[stk -1]>“The frequency of lymph node metastases in superficial squamous cell carcinoma of the esophagus … depends on the depth of invasion,” said Dr. Iizu­ka. “Accordingly, a therapeutic strategy has become feasible whereby endoscopic submucos­al dissection aimed at local con­trol is undertaken first, followed by considering additional treat­ment based on the results of the histological examination.”<[etk]>

<[stk -1]>The patients all had T1 tu­mors and clinically node-nega­tive (cN0) status as determined by endoscopy, endoscopic ultra­sound, CT, and PET imaging. They had endoscopic resection, either endoscopic mucosal re­section (EMR) before March 2005 or endoscopic submucosal dissection (ESD) after.<[etk]>

<[stk -3]>Histologic evaluation of the endoscopically resected lesions showed that 140 patients had pathologic M3, SM1, or SM2 tu­mors, and they therefore received additional treatment. Patients found to have pathologic M1 or M2 tumors were followed.<[etk]>

Dr. Iizuka focused on results for 27 patients who underwent subsequent surgical resection and 56 who underwent subse­quent chemoradiation, with the choice between these two op­tions left to patients after dis­cussion of each in their case.

Overall, these patients had a mean age of about 63 years, and 87% were men. Tumors were roughly equally located in the upper, middle, and lower esophagus; the mean size was 42 mm in the surgery group and 26 mm in the chemoradia­tion group. The majority of en­doscopic resections were ESD.

In the surgery group, patients more often had a three-field lymph node dissection (59%) than a two-field one (41%). In the chemoradiation group, the majority of patients received 40-45 Gy of radiation (86%) and low-dose 5-fluorouracil and cis­platin chemotherapy (57%).

Results for all 140 patients who underwent endoscopic re­section showed a resection rate of 81% and an R0 resection rate of 72%. Overall, 15% of pa­tients had a complication from the procedure, with stenosis, at 11%, being the most common.

The main complications were anastomotic stenosis (15% of patients) and recurrent nerve palsy (7%). Also, 7% of patients were found to have residual can­cer and 4% were found to have lymph node metastases. The main serious complication of chemoradiation was grade 3 leukopenia (14%). There were no treatment-related deaths or grade 4 adverse events.

The median duration of fol­low-up was 42.5 months in the surgery group and 33 months in the chemoradiation group.

None of the patients had a lo­cal recurrence. The actuarial 5-year rates of relapse-free survival were 100% and 88%, re­spectively; the actuarial 5-year rates of overall survival were 100% and 76%, respectively.

Dr. Iizuka reported no rele­vant conflicts of interest.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and is as im­portant as knowing how to ready an EKG or an x-ray, James A. Avery, M.D., said. “What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical,” Dr. Avery said at this year’s AMDA – Dedicated to Long Term Care Medicine annual meeting.

“Giving bad news … takes desire, courage, and prac­tice,” said Dr. Avery. “Patients deserve to get bad news delivered with compassion, hope, and integrity.”

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a com­passionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that fo­cuses on skilled nursing, assisted living, and rehabilita­tion therapy. Also, always provide an appropriate prognosis. “It’s your obligation to bring this up. Patients and families may be afraid to ask.”

What can happen if the conversation is not done cor­rectly? “If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years,” said Dr. Avery.

“I was particularly bad at giving bad news at first,” he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, New York, for example.

<[stk -1]>“I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Mon­day. It is too chaotic,” Dr. Avery said. Schedule the pa­tient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfort­able, private place with tissues available, he added.<[etk]>

Next, determine where each patient is in terms of un­derstanding his or her illness. “Explore and ask,” Dr. Av­ery said. Good questions include:

<[stk -3]>P Is there anyone you want with you in the conversation? <[etk]>

P How do you understand what has happened to you medically?

P What have doctors told you about this illness?

P What do you think caused this illness?

“I cannot tell you how many patients with colon can­cer thought they had it because they took too many antacids,” Dr. Avery said. “Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer and felt guilty that she was leaving her family because she ate burgers instead of salads.”

Also, determine how much the patient wants to know. “About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment.” Physicians also can be in­strumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symp­tom is going to get worse and worse and crescendo in pain before they die. “How do people with COPD die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away.”

Intentionally develop and use a compassionate tone,
Dr. Avery said. This is important because patients sur­veyed after receiving bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude.

Allow for silence. Let the message sink in. “Give the patient plenty of time to react, respond, and ask ques­tions.” Also allow tears – “That can be a real problem for a lot of doctors.”

<[stk -1]>A challenge for physicians is to be empathetic with­out breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. “Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive.”<[etk]>

“One reason physicians think they do not give bad news well is they fear their own response; that they will break down,” Dr. Avery said. Try to determine the pa­tient’s attitude and reflect it back to them. “This is what you do when things get emotional. And they will cor­rect you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’ ”

Another important thing to ask patients is, “Have the doctors told you how long you have?” An accurate prog­nosis will help patients and family prepare, Dr. Avery said. “You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care set­ting, because no one has told them.” Less-experienced doctors and doctors who have had a long and strong relationship with a patient can be especially poor at prognostication, he said.

<[stk -1]>Be completely honest and avoid stating a precise amount of time, such as “3 months.” “I say, ‘It could be weeks instead of months,’ or ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is,” Dr. Avery said. <[etk]>

I have checked the following facts in my story: (Please initial each.)

If you still do not feel comfortable giving the patient bad news, refer the patient to someone who does.

“Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this,” Dr. Avery said.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and is as im­portant as knowing how to ready an EKG or an x-ray, James A. Avery, M.D., said. “What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical,” Dr. Avery said at this year’s AMDA – Dedicated to Long Term Care Medicine annual meeting.

“Giving bad news … takes desire, courage, and prac­tice,” said Dr. Avery. “Patients deserve to get bad news delivered with compassion, hope, and integrity.”

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a com­passionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that fo­cuses on skilled nursing, assisted living, and rehabilita­tion therapy. Also, always provide an appropriate prognosis. “It’s your obligation to bring this up. Patients and families may be afraid to ask.”

What can happen if the conversation is not done cor­rectly? “If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years,” said Dr. Avery.

“I was particularly bad at giving bad news at first,” he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, New York, for example.

<[stk -1]>“I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Mon­day. It is too chaotic,” Dr. Avery said. Schedule the pa­tient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfort­able, private place with tissues available, he added.<[etk]>

Next, determine where each patient is in terms of un­derstanding his or her illness. “Explore and ask,” Dr. Av­ery said. Good questions include:

<[stk -3]>P Is there anyone you want with you in the conversation? <[etk]>

P How do you understand what has happened to you medically?

P What have doctors told you about this illness?

P What do you think caused this illness?

“I cannot tell you how many patients with colon can­cer thought they had it because they took too many antacids,” Dr. Avery said. “Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer and felt guilty that she was leaving her family because she ate burgers instead of salads.”

Also, determine how much the patient wants to know. “About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment.” Physicians also can be in­strumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symp­tom is going to get worse and worse and crescendo in pain before they die. “How do people with COPD die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away.”

Intentionally develop and use a compassionate tone,
Dr. Avery said. This is important because patients sur­veyed after receiving bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude.

Allow for silence. Let the message sink in. “Give the patient plenty of time to react, respond, and ask ques­tions.” Also allow tears – “That can be a real problem for a lot of doctors.”

<[stk -1]>A challenge for physicians is to be empathetic with­out breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. “Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive.”<[etk]>

“One reason physicians think they do not give bad news well is they fear their own response; that they will break down,” Dr. Avery said. Try to determine the pa­tient’s attitude and reflect it back to them. “This is what you do when things get emotional. And they will cor­rect you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’ ”

Another important thing to ask patients is, “Have the doctors told you how long you have?” An accurate prog­nosis will help patients and family prepare, Dr. Avery said. “You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care set­ting, because no one has told them.” Less-experienced doctors and doctors who have had a long and strong relationship with a patient can be especially poor at prognostication, he said.

<[stk -1]>Be completely honest and avoid stating a precise amount of time, such as “3 months.” “I say, ‘It could be weeks instead of months,’ or ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is,” Dr. Avery said. <[etk]>

I have checked the following facts in my story: (Please initial each.)

If you still do not feel comfortable giving the patient bad news, refer the patient to someone who does.

“Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this,” Dr. Avery said.

TAMPA – Sharing bad news with patients might not be easy, but it’s a skill physicians can learn and is as im­portant as knowing how to ready an EKG or an x-ray, James A. Avery, M.D., said. “What I am proposing is that giving bad news well is a fundamental long-term care physician skill, and competence in this area is critical,” Dr. Avery said at this year’s AMDA – Dedicated to Long Term Care Medicine annual meeting.

“Giving bad news … takes desire, courage, and prac­tice,” said Dr. Avery. “Patients deserve to get bad news delivered with compassion, hope, and integrity.”

Plan ahead for the conversation; start with what the patient knows and wants to know; and develop a com­passionate tone, said Dr. Avery, chief medical officer at Golden Living in Washington, a corporation that fo­cuses on skilled nursing, assisted living, and rehabilita­tion therapy. Also, always provide an appropriate prognosis. “It’s your obligation to bring this up. Patients and families may be afraid to ask.”

What can happen if the conversation is not done cor­rectly? “If bad news is given poorly, it can rob hope and create distress, confusion, and anxiety. It can weaken the patient’s faith and set off a chain of events that adversely affects the survivors for years,” said Dr. Avery.

“I was particularly bad at giving bad news at first,” he said. A pulmonologist by training, he also worked for years in hospice care in both Florida and New York. He spoke with patients who transitioned to hospice from Memorial Sloan-Kettering Cancer Center, New York, for example.

<[stk -1]>“I learned quickly that if I was going to give bad news, not to schedule the patient for midmorning on a Mon­day. It is too chaotic,” Dr. Avery said. Schedule the pa­tient for the first appointment after lunch or at the end of the day. Allow sufficient time and create a comfort­able, private place with tissues available, he added.<[etk]>

Next, determine where each patient is in terms of un­derstanding his or her illness. “Explore and ask,” Dr. Av­ery said. Good questions include:

<[stk -3]>P Is there anyone you want with you in the conversation? <[etk]>

P How do you understand what has happened to you medically?

P What have doctors told you about this illness?

P What do you think caused this illness?

“I cannot tell you how many patients with colon can­cer thought they had it because they took too many antacids,” Dr. Avery said. “Also, I had one woman with breast cancer who responded ‘Burger King.’ She had read an article that fatty foods caused breast cancer and felt guilty that she was leaving her family because she ate burgers instead of salads.”

Also, determine how much the patient wants to know. “About 90% of patients want full information [about their condition], but everyone wants to know everything about treatment.” Physicians also can be in­strumental in allaying end-of-life fears, Dr. Avery said. Regardless of illness, most patients think some symp­tom is going to get worse and worse and crescendo in pain before they die. “How do people with COPD die? Yes, the symptoms get worse, but with COPD, they get COPD narcosis, get sleepy, and drift away.”

Intentionally develop and use a compassionate tone,
Dr. Avery said. This is important because patients sur­veyed after receiving bad news said the attitude of the person who spoke with them was the most important factor. The clarity of the message and privacy were also important, but they ranked far behind clinician attitude.

Allow for silence. Let the message sink in. “Give the patient plenty of time to react, respond, and ask ques­tions.” Also allow tears – “That can be a real problem for a lot of doctors.”

<[stk -1]>A challenge for physicians is to be empathetic with­out breaking down completely, Dr. Avery said. When working in hospice care in New York, he frequently spent the day traveling by subway to clients’ residences. “Am I going to travel around weeping? No. You have to somehow try to meet where they are, but you cannot go there completely. It would be self-destructive.”<[etk]>

“One reason physicians think they do not give bad news well is they fear their own response; that they will break down,” Dr. Avery said. Try to determine the pa­tient’s attitude and reflect it back to them. “This is what you do when things get emotional. And they will cor­rect you if you’re wrong. If you say ‘You sound angry,’ they might say ‘No, I’m upset.’ ”

Another important thing to ask patients is, “Have the doctors told you how long you have?” An accurate prog­nosis will help patients and family prepare, Dr. Avery said. “You have to tell them. If you don’t, they will seek a second opinion and/or leave the long-term care set­ting, because no one has told them.” Less-experienced doctors and doctors who have had a long and strong relationship with a patient can be especially poor at prognostication, he said.

<[stk -1]>Be completely honest and avoid stating a precise amount of time, such as “3 months.” “I say, ‘It could be weeks instead of months,’ or ‘It could be months instead of years.’ If they ask for a more precise prognosis, tell them it’s difficult to say, because it is,” Dr. Avery said. <[etk]>

I have checked the following facts in my story: (Please initial each.)

If you still do not feel comfortable giving the patient bad news, refer the patient to someone who does.

“Call in hospice, call in palliative care. If you cannot give that bad news, you are obligated to do this,” Dr. Avery said.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; [email protected]

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; [email protected]

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

SAN FRANCISCO – Pretreatment ex­pression of ERCC1 in localized esophageal and gastroesophageal ade­nocarcinomas is a marker for outcomes among patients given trimodality thera­py that includes oxaliplatin-based chemoradiation, investigators reported from a prospective study.

Fully 58% of the 55 patients studied from the Southwest Oncology Group (SWOG) S0356 trial had tumors ex­pressing a high level of mRNA for ERCC1, a key gene in the repair of plat­inum- and radiation-induced DNA dam­age.«http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=103&abstractID=71402»

Compared with their counterparts whose tumors had low expression, these patients were nearly three times more likely to experience progression and more than twice as likely to die, accord­ing to results reported at the meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

“ERCC1 mRNA level is a very promis­ing pretreatment biomarker in patients with localized esophageal and gastroe­sophageal adenocarcinoma treated with trimodality treatment,” asserted lead in­vestigator Dr. Pierre O. Bohanes. “Based on these and published data, the SWOG is planning a prospective biomarker-dri­ven clinical trial.”

“In contrast to the growing number of predictive biomarkers for anticancer agents, there are no established bio­markers to select patients who will ben­efit most from chemoradiation,” he noted. “Utilization of predictive bio­markers to select therapy should lead to higher cure rates.”

The phase II trial, which was largely community based, enrolled patients with clinical stage II or III esophageal or gas­troesophageal junction adenocarcinoma. They underwent tumor biopsy, then chemoradiation (oxaliplatin, 5-fluo­rouracil, and 45-Gy external beam radi­ation), then surgery, and finally more chemotherapy (oxaliplatin and 5-fluo­rouracil).

Response Genetics Inc., manufacturer of several biomarker assays, analyzed tumor ERCC1 mRNA expression for the 55 patients who had sufficient pretreatment tumor tissue. Laser-capture mi­crodissection was used to ensure that only tumor cells were analyzed.

“ERCC1 has been shown to be a crit­ical gene in DNA repair,” Dr. Bohanes explained. “ERCC1 is involved in the nucleotide excision repair pathway, which recognizes and removes platinum-induced DNA adducts.” Higher expres­
sion is associated with resistance to plat­inum compounds, including cisplatin, oxaliplatin, and carboplatin.

“Also more recently, ERCC1 has been shown to be involved in the double-strand break repair pathway, which re­pairs radiation-induced damage,” he further observed.

Tumors were classified as having a high or low level of ERCC1 expression using a cutoff mRNA level of greater than 1.7 for high expression, as estab­lished in previous studies.

The 55 patients studied had a median age of 64 years. Most were men (93%) and white (94%), and had esophageal tu­mors (62%). One-fourth of them were found to have a pathological complete response at the time of surgery.

The median duration of follow-up was 36.8 months, reported Dr. Bohanes, a re­search fellow in medical oncology at the University of Southern California in Los Angeles.

Results showed that patients having high vs. low tumor expression of ERCC1 had a nearly tripled risk of progression (hazard ratio, 2.97; P = .006).«change in ONCR rendition» The medi­an duration of progression-free survival was 14.8 months for the former but was not reached for the latter. Corresponding 2-year rates of progression-free survival were 17% and 67%.

Similarly, patients with tumors having high vs. low expression of ERCC1 had a more than doubling of the risk of death (HR, 2.32; P = .047). «change in ONCR rendition» The median dura­tion of overall survival was 22.4 months for the former but was not reached for the latter. Corresponding 2-year rates of overall survival were 37% and 72%.

Expression of ERCC1 was not associ­ated with pathological complete re­sponse. Also, expression of a host of other genes – XPD and RRM1 (associat­ed with DNA repair), GSTP1 (associated with platinum detoxification), and TS, TP, and DPD (associated with 5-fluo­rouracil metabolism) – was not associat­ed with any of the outcomes studied.

“Biomarker studies are feasible within cooperative groups,” commented Dr. Bohanes, but adequate tissue was avail­able for only 55 of 92 eligible patients. Hence, “future trials need to request ad­ditional endoscopic biopsies to allow for sufficient tumor tissue collection.”

A study shortcoming was an inability to determine whether ERCC1 expression correlates with disease stage, he ac­knowledged.

“The design of this study unfortu­nately did not require preoperative en­doscopic ultrasound because it was thought that it would have hampered the
recruitment of this trial,” he said. “And often, in the community setting, endoscopic ultrasound is not avail­able.”

Also, the study could not deter­mine whether ERCC1 expression is a prognostic marker. “We would need a control arm without platinum agent,” he noted.

<[stk 3]>“I think that the patients with high expression are not benefiting from this treatment” and should be treated with alternative treatments, commented Dr. Heinz-Josef Lenz, senior investigator and chair of the gastrointestinal oncology program at the University of Southern Cali­fornia. <[etk]>

“We have choices, and I think that would certainly be part of the new concept and design going forward, ” he added.

<[stk 3]>Dr. Lenz agreed with an attendee that recruiting patients with esophageal and gastroesophageal cancer to randomized trials has been difficult in the past and it might therefore take many years to obtain important biomarker data. But adaptive trial designs are ad­dressing this issue.<[etk]>

I have checked the following facts in my story: (Please initial each.)

Meeting: 3660-11

Drug names and dosages: SML jsm

Lab test values and their units: n/a na

Citation (e.g., JAMA 2008;299:785-92): n/a na

Investigators’ names and affiliations: SML jsm

All other proper names (e.g., clinical trials; geographic, company, and test names): SML jsm

Investigators’ conflicts of interest and sponsor of study: SML jsm

Please provide your best contact number and email for questions on this story: (206) 393-2459; [email protected]

Notes:

(1) Abstract 2; log in on main ASCO page first -- http://www.asco.org

username: gi_pressaccess

password: pre$$1

Go to Virtual Meeting. Note: search function for this meeting is not working well yet, so better to look by track.

(2) Either they did not show the conflicts of interest slides at the start of the session or they blew through them at lightspeed. I don’t have any photos of them and they are not up on the Web site. So Dr. Lenz’s conflicts come from a slide in Dr. Bohanes’ talk, where the nature of the conflicts was not given.

“I think we are incorporating now more technologies with the design, which may be more flexible to adapt new findings so that we are not stuck for the next 3 or 5 years to a trial be­cause of low accrual,” he said.

Dr. Bohanes reported that he had no relevant conflicts of interest.

Dr. Lenz reported having relation­ships with Response Genetics Inc. and with Sanofi-Aventis, manufac­turer of oxaliplatin (Eloxatin). 

A scientific statement from the American Heart As­sociation provides guidance for the management of the more severe forms of venous thromboembolism.

The statement focuses on three areas: massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pul­monary hypertension. “The goal is to provide practi­cal advice to enable the busy clinician to optimize the management of patients with these severe manifesta­tions of [venous thromboembolism],” said the writing committee, cochaired by Dr. Michael R. Jaff and Dr. M. Sean McMurtry (Circulation 2011 Mar. 21 [doi:10.1161/CIR.0b013e318214914f]).« http://www.theheart.org/article/1200965.do»

<[stk -1]>In an interview, Dr. McMurtry noted that because these disease areas have less data to support manage­ment strategies than do other areas of cardiovascular medicine, most of the recommendations in the docu­ment are class II (“it is reasonable” or “may be consid­ered”) with level of evidence B or C (limited populations evaluated). “The authors hope that this document will inspire more research into these conditions,” said Dr. McMurtry of the University of Alberta, Edmonton.<[etk]>

<[stk -3]>The document begins by defining “massive,” “sub­massive,” and “low-risk” pulmonary embolism (PE), and provides data for the various techniques used to identify patients at increased risk for adverse short-term outcomes in acute PE. <[etk]>

Beyond initial heparin anticoagulation therapy, the use of fibrinolytic drugs is reasonable for patients with massive acute PE and an acceptable risk of bleeding complications, the statement said. It may also be con­sidered for patients with submassive acute PE judged to have clinical evidence of an adverse prognosis (new hemodynamic instability, worsening respiratory insuf­ficiency, severe right ventricle [RV] dysfunction, or major myocardial necrosis) and a low risk of bleeding.

Fibrinolysis is not recommended for patients with low-risk PE, or submassive PE with minor RV dys­function, minor myocardial necrosis, and no clinical worsening. Fibrinolysis is also not recommended for undifferentiated cardiac arrest, wrote Dr. McMurtry and Dr. Jaff of Harvard Medical School, and coauthors.

In addition, recommendations are provided for oth­er areas in which data are sparse and optimal manage­ment is unclear, including catheter-based therapies. Transcatheter procedures can be performed as an al­ternative to thrombolysis when there are contraindi­cations or when emergency surgical thrombectomy is unavailable or contraindicated. Catheter interventions can also be performed when thrombolysis has failed to improve hemodynamics in the acute setting.

Hybrid therapy that includes both catheter-based clot fragmentation and local thrombolysis is an emerging strategy, the committee noted.

Adult patients with any confirmed acute PE who have contraindications to anticoagulation or have active bleeding should receive an inferior vena cava (IVC) fil­ter. Further specific guidance is given for the type of fil­ter and for monitoring.

<[stk -1]>Iliofemoral Deep Vein Thrombosis (IVDVT) refers to complete or partial thrombosis of any part of the iliac vein or the common femoral vein, with or without in­volvement of other lower-extremity veins or the IVC. Under this heading, the document addresses the use of initial coagulant therapy, long-term anticoagulant ther­apy, compression therapy, IVC filters, and thrombore­ductive strategies, including systemic, catheter-directed, percutaneous mechanical, and pharmacomechanical thrombolysis. Surgical venous thrombectomy is also dis­cussed as an alternative method of thrombus removal. <[etk]>

«qc'er: pls fact check these next 2 grafs»<[stk -2]>“Reasonable” angiopathy and stenting options for older adolescents and adults include the use of percuta­neous transluminal venous angioplasty and stent place­ment in the iliac vein to treat obstructive lesions after catheter-directed thrombolysis (CDT), pharmacome­chanical CDT (PCDT), or surgical venous thrombecto­my, and placement of iliac vein stents to reduce postthrombotic symptoms and heal venous ulcers in pa­tients with advanced postthrombotic symptoms and il­iac vein obstruction. “For obstructive iliac vein lesions that extend into the common femoral vein, caudal ex­tension of stents into the common femoral vein is rea­sonable if unavoidable.” Guidelines regarding subsequent therapeutic anticoagulation are also provided. <[etk]>

The authors noted that “the use of percutaneous transluminal venous angioplasty in children may be rea­sonable, but this practice has not been well studied and may be associated with a greater risk of vasospasm.”

The section on chronic thromboembolic pulmonary hypertension (CTEPH) outlines the classification, risk factors, clinical presentation, diagnosis, and treatment with pulmonary endarterectomy and medical therapies. The condition is a syndrome of dyspnea, fatigue, and exercise intolerance caused by proximal thromboem­bolic obstruction and distal remodeling of the pul­monary circulation that leads to elevated pulmonary artery pressure and progressive RV failure.

Patients with unexplained dyspnea, exercise intoler­ance, or clinical evidence of right-sided heart failure, with or without a prior history of symptomatic venous thromboembolism, should be evaluated for CTEPH, and it is reasonable to evaluate patients with an echocar­diogram 6 weeks after an acute pulmonary embolism to screen for persistent pulmonary hypertension that may predict the development of CTEPH.

Patients with objectively proven CTEPH should be promptly evaluated for pulmonary endarterectomy, even if symptoms are mild, and receive indefinite ther­apeutic anticoagulation in the absence of contraindi­cations, they advised.

I have checked the following facts in my story: (Please initial each.)

 lf MET    drug names and dosages -

 lf MET    lab test values and their units -

lf MET     whether nos. are correct and add up, and whether percentages based on those nos. are correct -

lf MET     citation (e.g., JAMA 2008;299:785-92) -

 lf MET    investigators’ names and affiliations -

 lf MET     all other proper names (e.g., clinical trials; geographic, company, and test names) –..

 lf MET    investigators' conflicts of interest and sponsor of study – 

Dr. McMurtry reported no relavant disclosures.

********* UNDERSET  1  LINES *********

A scientific statement from the American Heart As­sociation provides guidance for the management of the more severe forms of venous thromboembolism.

The statement focuses on three areas: massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pul­monary hypertension. “The goal is to provide practi­cal advice to enable the busy clinician to optimize the management of patients with these severe manifesta­tions of [venous thromboembolism],” said the writing committee, cochaired by Dr. Michael R. Jaff and Dr. M. Sean McMurtry (Circulation 2011 Mar. 21 [doi:10.1161/CIR.0b013e318214914f]).« http://www.theheart.org/article/1200965.do»

<[stk -1]>In an interview, Dr. McMurtry noted that because these disease areas have less data to support manage­ment strategies than do other areas of cardiovascular medicine, most of the recommendations in the docu­ment are class II (“it is reasonable” or “may be consid­ered”) with level of evidence B or C (limited populations evaluated). “The authors hope that this document will inspire more research into these conditions,” said Dr. McMurtry of the University of Alberta, Edmonton.<[etk]>

<[stk -3]>The document begins by defining “massive,” “sub­massive,” and “low-risk” pulmonary embolism (PE), and provides data for the various techniques used to identify patients at increased risk for adverse short-term outcomes in acute PE. <[etk]>

Beyond initial heparin anticoagulation therapy, the use of fibrinolytic drugs is reasonable for patients with massive acute PE and an acceptable risk of bleeding complications, the statement said. It may also be con­sidered for patients with submassive acute PE judged to have clinical evidence of an adverse prognosis (new hemodynamic instability, worsening respiratory insuf­ficiency, severe right ventricle [RV] dysfunction, or major myocardial necrosis) and a low risk of bleeding.

Fibrinolysis is not recommended for patients with low-risk PE, or submassive PE with minor RV dys­function, minor myocardial necrosis, and no clinical worsening. Fibrinolysis is also not recommended for undifferentiated cardiac arrest, wrote Dr. McMurtry and Dr. Jaff of Harvard Medical School, and coauthors.

In addition, recommendations are provided for oth­er areas in which data are sparse and optimal manage­ment is unclear, including catheter-based therapies. Transcatheter procedures can be performed as an al­ternative to thrombolysis when there are contraindi­cations or when emergency surgical thrombectomy is unavailable or contraindicated. Catheter interventions can also be performed when thrombolysis has failed to improve hemodynamics in the acute setting.

Hybrid therapy that includes both catheter-based clot fragmentation and local thrombolysis is an emerging strategy, the committee noted.

Adult patients with any confirmed acute PE who have contraindications to anticoagulation or have active bleeding should receive an inferior vena cava (IVC) fil­ter. Further specific guidance is given for the type of fil­ter and for monitoring.

<[stk -1]>Iliofemoral Deep Vein Thrombosis (IVDVT) refers to complete or partial thrombosis of any part of the iliac vein or the common femoral vein, with or without in­volvement of other lower-extremity veins or the IVC. Under this heading, the document addresses the use of initial coagulant therapy, long-term anticoagulant ther­apy, compression therapy, IVC filters, and thrombore­ductive strategies, including systemic, catheter-directed, percutaneous mechanical, and pharmacomechanical thrombolysis. Surgical venous thrombectomy is also dis­cussed as an alternative method of thrombus removal. <[etk]>

«qc'er: pls fact check these next 2 grafs»<[stk -2]>“Reasonable” angiopathy and stenting options for older adolescents and adults include the use of percuta­neous transluminal venous angioplasty and stent place­ment in the iliac vein to treat obstructive lesions after catheter-directed thrombolysis (CDT), pharmacome­chanical CDT (PCDT), or surgical venous thrombecto­my, and placement of iliac vein stents to reduce postthrombotic symptoms and heal venous ulcers in pa­tients with advanced postthrombotic symptoms and il­iac vein obstruction. “For obstructive iliac vein lesions that extend into the common femoral vein, caudal ex­tension of stents into the common femoral vein is rea­sonable if unavoidable.” Guidelines regarding subsequent therapeutic anticoagulation are also provided. <[etk]>

The authors noted that “the use of percutaneous transluminal venous angioplasty in children may be rea­sonable, but this practice has not been well studied and may be associated with a greater risk of vasospasm.”

The section on chronic thromboembolic pulmonary hypertension (CTEPH) outlines the classification, risk factors, clinical presentation, diagnosis, and treatment with pulmonary endarterectomy and medical therapies. The condition is a syndrome of dyspnea, fatigue, and exercise intolerance caused by proximal thromboem­bolic obstruction and distal remodeling of the pul­monary circulation that leads to elevated pulmonary artery pressure and progressive RV failure.

Patients with unexplained dyspnea, exercise intoler­ance, or clinical evidence of right-sided heart failure, with or without a prior history of symptomatic venous thromboembolism, should be evaluated for CTEPH, and it is reasonable to evaluate patients with an echocar­diogram 6 weeks after an acute pulmonary embolism to screen for persistent pulmonary hypertension that may predict the development of CTEPH.

Patients with objectively proven CTEPH should be promptly evaluated for pulmonary endarterectomy, even if symptoms are mild, and receive indefinite ther­apeutic anticoagulation in the absence of contraindi­cations, they advised.

I have checked the following facts in my story: (Please initial each.)

 lf MET    drug names and dosages -

 lf MET    lab test values and their units -

lf MET     whether nos. are correct and add up, and whether percentages based on those nos. are correct -

lf MET     citation (e.g., JAMA 2008;299:785-92) -

 lf MET    investigators’ names and affiliations -

 lf MET     all other proper names (e.g., clinical trials; geographic, company, and test names) –..

 lf MET    investigators' conflicts of interest and sponsor of study – 

Dr. McMurtry reported no relavant disclosures.

********* UNDERSET  1  LINES *********

A scientific statement from the American Heart As­sociation provides guidance for the management of the more severe forms of venous thromboembolism.

The statement focuses on three areas: massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pul­monary hypertension. “The goal is to provide practi­cal advice to enable the busy clinician to optimize the management of patients with these severe manifesta­tions of [venous thromboembolism],” said the writing committee, cochaired by Dr. Michael R. Jaff and Dr. M. Sean McMurtry (Circulation 2011 Mar. 21 [doi:10.1161/CIR.0b013e318214914f]).« http://www.theheart.org/article/1200965.do»

<[stk -1]>In an interview, Dr. McMurtry noted that because these disease areas have less data to support manage­ment strategies than do other areas of cardiovascular medicine, most of the recommendations in the docu­ment are class II (“it is reasonable” or “may be consid­ered”) with level of evidence B or C (limited populations evaluated). “The authors hope that this document will inspire more research into these conditions,” said Dr. McMurtry of the University of Alberta, Edmonton.<[etk]>

<[stk -3]>The document begins by defining “massive,” “sub­massive,” and “low-risk” pulmonary embolism (PE), and provides data for the various techniques used to identify patients at increased risk for adverse short-term outcomes in acute PE. <[etk]>

Beyond initial heparin anticoagulation therapy, the use of fibrinolytic drugs is reasonable for patients with massive acute PE and an acceptable risk of bleeding complications, the statement said. It may also be con­sidered for patients with submassive acute PE judged to have clinical evidence of an adverse prognosis (new hemodynamic instability, worsening respiratory insuf­ficiency, severe right ventricle [RV] dysfunction, or major myocardial necrosis) and a low risk of bleeding.

Fibrinolysis is not recommended for patients with low-risk PE, or submassive PE with minor RV dys­function, minor myocardial necrosis, and no clinical worsening. Fibrinolysis is also not recommended for undifferentiated cardiac arrest, wrote Dr. McMurtry and Dr. Jaff of Harvard Medical School, and coauthors.

In addition, recommendations are provided for oth­er areas in which data are sparse and optimal manage­ment is unclear, including catheter-based therapies. Transcatheter procedures can be performed as an al­ternative to thrombolysis when there are contraindi­cations or when emergency surgical thrombectomy is unavailable or contraindicated. Catheter interventions can also be performed when thrombolysis has failed to improve hemodynamics in the acute setting.

Hybrid therapy that includes both catheter-based clot fragmentation and local thrombolysis is an emerging strategy, the committee noted.

Adult patients with any confirmed acute PE who have contraindications to anticoagulation or have active bleeding should receive an inferior vena cava (IVC) fil­ter. Further specific guidance is given for the type of fil­ter and for monitoring.

<[stk -1]>Iliofemoral Deep Vein Thrombosis (IVDVT) refers to complete or partial thrombosis of any part of the iliac vein or the common femoral vein, with or without in­volvement of other lower-extremity veins or the IVC. Under this heading, the document addresses the use of initial coagulant therapy, long-term anticoagulant ther­apy, compression therapy, IVC filters, and thrombore­ductive strategies, including systemic, catheter-directed, percutaneous mechanical, and pharmacomechanical thrombolysis. Surgical venous thrombectomy is also dis­cussed as an alternative method of thrombus removal. <[etk]>

«qc'er: pls fact check these next 2 grafs»<[stk -2]>“Reasonable” angiopathy and stenting options for older adolescents and adults include the use of percuta­neous transluminal venous angioplasty and stent place­ment in the iliac vein to treat obstructive lesions after catheter-directed thrombolysis (CDT), pharmacome­chanical CDT (PCDT), or surgical venous thrombecto­my, and placement of iliac vein stents to reduce postthrombotic symptoms and heal venous ulcers in pa­tients with advanced postthrombotic symptoms and il­iac vein obstruction. “For obstructive iliac vein lesions that extend into the common femoral vein, caudal ex­tension of stents into the common femoral vein is rea­sonable if unavoidable.” Guidelines regarding subsequent therapeutic anticoagulation are also provided. <[etk]>

The authors noted that “the use of percutaneous transluminal venous angioplasty in children may be rea­sonable, but this practice has not been well studied and may be associated with a greater risk of vasospasm.”

The section on chronic thromboembolic pulmonary hypertension (CTEPH) outlines the classification, risk factors, clinical presentation, diagnosis, and treatment with pulmonary endarterectomy and medical therapies. The condition is a syndrome of dyspnea, fatigue, and exercise intolerance caused by proximal thromboem­bolic obstruction and distal remodeling of the pul­monary circulation that leads to elevated pulmonary artery pressure and progressive RV failure.

Patients with unexplained dyspnea, exercise intoler­ance, or clinical evidence of right-sided heart failure, with or without a prior history of symptomatic venous thromboembolism, should be evaluated for CTEPH, and it is reasonable to evaluate patients with an echocar­diogram 6 weeks after an acute pulmonary embolism to screen for persistent pulmonary hypertension that may predict the development of CTEPH.

Patients with objectively proven CTEPH should be promptly evaluated for pulmonary endarterectomy, even if symptoms are mild, and receive indefinite ther­apeutic anticoagulation in the absence of contraindi­cations, they advised.

I have checked the following facts in my story: (Please initial each.)

 lf MET    drug names and dosages -

 lf MET    lab test values and their units -

lf MET     whether nos. are correct and add up, and whether percentages based on those nos. are correct -

lf MET     citation (e.g., JAMA 2008;299:785-92) -

 lf MET    investigators’ names and affiliations -

 lf MET     all other proper names (e.g., clinical trials; geographic, company, and test names) –..

 lf MET    investigators' conflicts of interest and sponsor of study – 

Dr. McMurtry reported no relavant disclosures.

********* UNDERSET  1  LINES *********

Patients who quit smoking shortly before undergo­ing surgery are not at increased risk of postopera­tive complications, compared with those who continue to smoke, according to a report published online in the Archives of Internal Medicine.

“Until some new evidence of harm emerges, firm ad­vice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time,” said Katie Myers, M.Sc., of Queen Mary, University of London and her associates.

<[stk -3]>Publication of a study in 1989 with 39 subjects sug­gested that “stopping smoking leads to a decrease in coughing and an increase in sputum production.” Al­though that article did not show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery “to minimize the increase in pulmonary complications in recent quitters.” <[etk]>

<[stk -2]>Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as “high quality” the three studies that also used biochem­ical testing to validate subjects’ self-report of their smok­ing status. These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.<[etk]>

<[stk -3]>Only one of the studies showed a significant effect of smoking cessation, and that was in favor of recent quit­ting. When the results were pooled, there was “no ben­eficial or detrimental effect of quitting within 8 weeks before surgery compared with continued smoking.” <[etk]><[stk -2]>The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications. <[etk]>

“In conclusion, there is currently no suggestion, ei­ther from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications,” the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archintern­med.2011.97]).

The reluctance to allow or encourage smoking ces­sation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has di­rectly examined mucociliary clearance in surgical pa­tients shortly after smoking cessation, and that study found no significant difference between surgical pa­tients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

im, ob               embargoed until 4 pm 3/14

{Copy eds. -- I had to get some of my figures from charts and tables because they weren't in the text of the article. -- mam}

I have checked the following facts in my story:

NA     Drug names and dosages

NA     Lab test values and their units

MM     Nos. are correct and add up, and percentages based on those nos. are correct

MM/ew   Citation

MM/ew     Investigators’ names and affiliations

MM /ew    All other proper names (e.g., clinical trials; geographic, company, and test names)

MM     Investigators’ conflicts of interest and sponsor of study

Best contact number = 301-325-5890; email = The study is limited by its observational nature and by the small number of studies available for review.

Ms. Myers reported no conflicts.

********* UNDERSET  1  LINES *********

Patients who quit smoking shortly before undergo­ing surgery are not at increased risk of postopera­tive complications, compared with those who continue to smoke, according to a report published online in the Archives of Internal Medicine.

“Until some new evidence of harm emerges, firm ad­vice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time,” said Katie Myers, M.Sc., of Queen Mary, University of London and her associates.

<[stk -3]>Publication of a study in 1989 with 39 subjects sug­gested that “stopping smoking leads to a decrease in coughing and an increase in sputum production.” Al­though that article did not show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery “to minimize the increase in pulmonary complications in recent quitters.” <[etk]>

<[stk -2]>Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as “high quality” the three studies that also used biochem­ical testing to validate subjects’ self-report of their smok­ing status. These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.<[etk]>

<[stk -3]>Only one of the studies showed a significant effect of smoking cessation, and that was in favor of recent quit­ting. When the results were pooled, there was “no ben­eficial or detrimental effect of quitting within 8 weeks before surgery compared with continued smoking.” <[etk]><[stk -2]>The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications. <[etk]>

“In conclusion, there is currently no suggestion, ei­ther from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications,” the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archintern­med.2011.97]).

The reluctance to allow or encourage smoking ces­sation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has di­rectly examined mucociliary clearance in surgical pa­tients shortly after smoking cessation, and that study found no significant difference between surgical pa­tients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

im, ob               embargoed until 4 pm 3/14

{Copy eds. -- I had to get some of my figures from charts and tables because they weren't in the text of the article. -- mam}

I have checked the following facts in my story:

NA     Drug names and dosages

NA     Lab test values and their units

MM     Nos. are correct and add up, and percentages based on those nos. are correct

MM/ew   Citation

MM/ew     Investigators’ names and affiliations

MM /ew    All other proper names (e.g., clinical trials; geographic, company, and test names)

MM     Investigators’ conflicts of interest and sponsor of study

Best contact number = 301-325-5890; email = The study is limited by its observational nature and by the small number of studies available for review.

Ms. Myers reported no conflicts.

********* UNDERSET  1  LINES *********

Patients who quit smoking shortly before undergo­ing surgery are not at increased risk of postopera­tive complications, compared with those who continue to smoke, according to a report published online in the Archives of Internal Medicine.

“Until some new evidence of harm emerges, firm ad­vice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time,” said Katie Myers, M.Sc., of Queen Mary, University of London and her associates.

<[stk -3]>Publication of a study in 1989 with 39 subjects sug­gested that “stopping smoking leads to a decrease in coughing and an increase in sputum production.” Al­though that article did not show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery “to minimize the increase in pulmonary complications in recent quitters.” <[etk]>

<[stk -2]>Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as “high quality” the three studies that also used biochem­ical testing to validate subjects’ self-report of their smok­ing status. These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.<[etk]>

<[stk -3]>Only one of the studies showed a significant effect of smoking cessation, and that was in favor of recent quit­ting. When the results were pooled, there was “no ben­eficial or detrimental effect of quitting within 8 weeks before surgery compared with continued smoking.” <[etk]><[stk -2]>The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications. <[etk]>

“In conclusion, there is currently no suggestion, ei­ther from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications,” the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archintern­med.2011.97]).

The reluctance to allow or encourage smoking ces­sation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has di­rectly examined mucociliary clearance in surgical pa­tients shortly after smoking cessation, and that study found no significant difference between surgical pa­tients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

im, ob               embargoed until 4 pm 3/14

{Copy eds. -- I had to get some of my figures from charts and tables because they weren't in the text of the article. -- mam}

I have checked the following facts in my story:

NA     Drug names and dosages

NA     Lab test values and their units

MM     Nos. are correct and add up, and percentages based on those nos. are correct

MM/ew   Citation

MM/ew     Investigators’ names and affiliations

MM /ew    All other proper names (e.g., clinical trials; geographic, company, and test names)

MM     Investigators’ conflicts of interest and sponsor of study

Best contact number = 301-325-5890; email = The study is limited by its observational nature and by the small number of studies available for review.

Ms. Myers reported no conflicts.

********* UNDERSET  1  LINES *********

FROM THE ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS

SAN DIEGO - An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the meeting.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.

FROM THE ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS

SAN DIEGO - An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the meeting.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.

FROM THE ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS

SAN DIEGO - An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the meeting.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.